by Dr. Yashashwini Reddy | Aug 27, 2025
Validation of Clean Room Pass Boxes 1. Introduction A pass box is an enclosed space with doors on both sides, installed between two areas of different cleanliness grades.It allows the transfer of materials with minimum air turbulence and controlled contamination...
by Dr. Yashashwini Reddy | Aug 18, 2025
Contamination Control Strategies for Manufacturing Area In pharmaceutical manufacturing, contamination control is critical to ensure product quality, patient safety, and regulatory compliance. Contamination can occur in the form of particulate, microbial, chemical, or...
by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) Here is a complete Standard Operating Procedure (SOP) for the Cleaning of Clean Area (Sterile Area) in pharmaceutical manufacturing, ensuring compliance with GMP and sterile environmental control requirements. 1.0...
by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) 1.0 Objective To lay down the procedure for cleaning, sanitization, and verification activities required to resume aseptic area operations after any maintenance work, ensuring compliance with GMP and sterility...
by Dr. Yashashwini Reddy | May 3, 2025
Restricted Access Barrier System (RABS) in Pharmaceuticals – Detailed Explanation 1. Introduction A Restricted Access Barrier System (RABS) is a contamination control technology used in the pharmaceutical industry, particularly in aseptic processing environments. It...
